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Lawmakers urge FDA to move forward on Unique Device Identification
Congress passes unique device identification language
In a major victory for Premier and its member hospitals, the Senate and House passed a bill last week that includes a provision requiring the Food and Drug Administration (FDA) to put into place a unique medical device identification system. President Bush signed the bill into law on September 27.
The unique device identification (UDI) language was included in the Food and Drug Administration Amendments Act of 2007 ( H.R. 3580 ), which would reauthorize user fee programs under the FDA and expand FDA’s authority to monitor medical devices and prescription drugs. The Senate passed H.R. 3580 September 20 by unanimous consent and the House approved the bill by a vote of 405-7 on September 19.
The UDI language was spurred by a May 7 letter to the FDA from Reps. Mike Doyle (D-PA), Pete Sessions (R-TX) and 24 of their colleagues asking the agency to move forward as soon as possible on a national UDI system. Rep. Darlene Hooley (D-OR), who worked on the UDI provision with Rep. Doyle, spoke in support of the language in a floor speech during House debate of the bill. “A UDI system will enable the FDA to detect warning signs of a defective device earlier and quickly respond to recalls. Every person with an artificial knee or hip, pacemaker, or one of the thousands of other medical devices will benefit once this UDI system is in place,” Hooley said.
Thanks to all the hard work of Premier hospitals and health systems who helped garner support of House and Senate members on this important issue. Premier will continue to work with the FDA and urge the agency’s prompt action in response to the congressional mandate for implementing a UDI system.